From: ReconnUSA@aol.com
Sent: Wednesday, May 14, 2003 1:59 PM
To: fdadockets@oc.fda.gov
Cc: LTKontnik@Reconnaissance-Intl.com
Subject: Docket No. 02N-0204-Comments-Bar Code
FDA Docket Management Branch (HFA-305)
Docket No. 02N-0204
Bar Code Label Requirements for Human Drug Products and Blood
http://www.fda.gov/dockets/ecomments
Dear Sirs:
Reconnaissance International is an authority of product counterfeiting and
diversion, with special focus on the security of pharmaceuticals (please see
www.Pharma-AntiCounterfeiting.Info). We are also a subcontractor in the FDA
supported Product Surety Program (see: www.ProductSurety.Org).
From our experience in the anticounterfeiting area, we do (as a private
company) have the following general comments on the above titled proposed
rules.
1) Consider other related activities in the finalization of the bar code
rules.
While medical errors and compliance are the main focus of the current
rulemaking effort, there are other important public health objectives that
could be advanced (or frustrated) by the current rules.
Authentication and traceability of drugs subject to counterfeiting (and/or
terrorist attack) is one of those objectives. Over the past two years,
counterfeits of approximately a dozen different drugs have entered the US
drug supply. Product unit labeling and track and trace technologies are a
main potential tool for fighting this problem and for adding security to the
drug supply. I strongly urge you to examine the work being done by the
Product Surety project and to consider this information as part of you final
rulemaking process.
One of the specific concerns with the proposed UCC linear codes and the
stacked
linear codes such as RS 114 is the limitation of alphanumeric characters
precludes inclusion of lot number, expiration date and serial numbers. Those
additional characters could be used for product authentication, as the US
treasury at some level uses serial numbers to authenticate currency. Space
for these additional
characters are already included in the 2-D codes used as standards by the
aerospace, automotive, and electronic industry.
2) Do not foreclose current and future bar coding and product identity
technologies.
The currently proposed regulations specify the use of the
"National Drug Code (NDC) number in a linear bar code." While this
information is important, the health care community should not be prevented
from adopting other
technologies, containing more information that could be useful in business
operations and in securing the drug supply against counterfeits and
terrorist attacks. Specifically, 2D bar codes and the developing MIT AutoID
EPC codes
should be allowed in addition to the linear codes.
Not to do this would cut off the FDA and the medical community from using the
best technology that exists and is being implemented today. We should not
freeze the system into using old technologies and prevent the introduction of
current technologies.
Language that looks to the future might also mitigate future obsolescence
complaints by hospitals, in that their purchasing decision for bar code
readers would consider using modern design CCD camera and adaptable software
driven readers, rather than simple linear reader with 1980s technology.
Foreclosing new technologies would not serve the public health, business
efficiency or administrative effectiveness.
Thank you for the opportunity to comment on these proposed rules.
Sincerely yours,
Lewis T. Kontnik
Principal
Reconnaissance Intl
5650 Greenwood Plaza Blvd #225K
Greenwood Village, CO 80111
USA
303 779 1096
Fax 303 779 3647
www.pharma-anticounterfeiting.info
www.productsurety.org
www.holopackholoprint.info
www.Reconnaissance-Intl.com
ACP SOLUTIONS USA - June 10-13, 2003
Crowne Plaza Ravinia, Atlanta, GA
ACP SOLUTIONS EUROPE - September 8-11, 2003
Radisson SAS Hotel, Dusseldorf, Germany
www.acpsolutions.info